Benign and malignant lesions, including lesions of the tongue, pharynx, and larynx, commonly occur in the oral cavity, pharynx and larynx which frequently require surgical removal. The most common malignancy of the mucosa or internal lining of the aforementioned structures is known as squamous cell carcinoma. Historically, these surgeries were done either with a very radical open surgical approach or by laser surgery. The former method is enormously invasive, requiring long recuperative times for the patient. The latter method suffers, among other things, from inherent problems of line-of-sight issues for the surgeon related to the fact that the optics, and most often the laser itself, are placed outside the mouth. In addition with traditional laser surgery the surgical tools allow for limited range of motion which limits the capability of the surgeon. Various retractors were developed to provide greater control of the instruments during such surgeries. Examples of such frames include the Feyh-Kastenbauer, Crowe-Davis, Davis-Geck, and Dingman retractors, each providing a slightly different design approach for the same or similar surgeries.
More recently, a technique referred to as TransOral Robotic Surgery (“TORS”) has been developed by head and neck surgeons at the University of Pennsylvania School of Medicine and approved by the FDA, for TransOralotolaryngologic surgical procedures to treat benign tumors and select malignant tumors of the mouth, voice box, tonsil, tongue and other parts of the throat. The benefits of this type of surgery are significant: 45,000 Americans and approximately 500,000 people worldwide are diagnosed with head and neck cancers each year. Head and neck tumor treatments often involve a combination of surgery, radiation therapy, and chemotherapy. In many cases, surgery offers the greatest chance of cure, yet conventional surgery may require an almost ear-to-ear incision across the throat or splitting the jaw, resulting in speech and swallowing deficits for patients. In comparison, the minimally invasive TORS approach, which accesses the surgical site through the mouth, has been shown to improve long term swallowing function and reduce risk of infection while speeding up the recovery time. When compared to traditional surgeries, after their cancers have been removed successfully, patients have been able to begin swallowing on their own sooner and leave the hospital earlier. TORS outcomes are markedly improved when compared to standard chemotherapy, radiation or traditional open surgical approaches for oropharyngeal cancer.
However, the present inventors discovered that conventional retractors and associated tools did not provide the line-of-sight or range of motion features necessary for TORS. U.S. Pat. No. 5,897,491 (the '491 patent), which is incorporated by reference herein, describes the so-called Feyh-Kastenbauer, or FK, retractor which initially appeared to be suited for this application. This retractor was useful for allowing better access for manually applied laser surgery and some other non-laser resections. But, as the present inventors found, significant limitations in commercial embodiments of this retractor existed, when applied to TORS, most notably the inability to adequately use the previous invention during robotic surgery. In particular, the frame of this retractor provided insufficient access to the patient's mouth for the robotic tools. Similarly, the present inventors discovered that the spatulas used to hold open the patient's mouth (described in the '491 patent as the labial-commissure spatula 5) provided insufficient access to the deeper portions of the patient's throat by the robotic arms. FIG. 1 and FIGS. 2A-2B show various embodiments and orientations of historically available spatulas for use with the FK retractor.